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CompletedPhase 2Results posted

GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP)

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Design, Prospective, Phase IIa Exploratory Clinical Trial to Evaluate the Efficacy and Safety of SC Administration of GV1001 0.56 or 1.12 mg/Day in Patients With PSP

Lead sponsor

GemVax & Kael

Asset

GV1001

Listed sites

Recruiting sites

Enrollment

actual

Study population

Frontotemporal dementia

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Change From the Baseline in the Total Score of PSP-rating Scale

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDGV1001-PSP-CL2-011

NCT IDNCT05819658

Timeline

Milestones

Study first posted2023-04-19actual

Study start2023-06-14actual

Primary completion2024-10-11actual

Study completion2024-10-11actual

Last update posted2026-02-10actual

Results first posted2026-02-10actual

Assets

Drug assets

GV1001

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age41 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients aged ≥41 years to ≤ 85 years.

•Clinical diagnosis of probable progressive supranuclear palsy (PSP).

•Patient is on a stable therapy for a neurological drug for at least 1 month prior to screening visit.

•Patients who are able to walk 3 meters or more independently or with assistive devices.

•Score 15 points ≥ on the Korean Mini-Mental Status Exam (K-MMSE) at the screening visit.

•Have reliable caregiver to accompany participant to all study visits.

•Patients and/or their representatives who have voluntarily provided a written consent for participation in this clinical study

Exclusion criteria

•Patients who have Presence of structural lesions or Suspected concurrent onset of central nervous system diseases based on the CT/MRI scan results and neurological examinations performed within 12 months of screening or at screening.

•Patients with a history of known or suspected seizures.

•Patients with a recent unexplained loss of consciousness within 3 months prior to screening or a history of significant head trauma with loss of consciousness.

•Patients with acute or unstable cardiovascular disease, uncontrolled hypertension, uncontrolled diabetes, or any other medical condition that can interfere with completing the clinical study.

•Patients with hypersensitivity reactions to the ingredients of the investigational product.

•Patients with a history of cancer within 5 years prior to screening.

•Patients with abnormal renal function.

•Patients with severe liver function abnormalities.

•Patients weighing ≤35 kg.

•Among the female subjects who does not agree to use proper contraception.

•Pregnant or breastfeeding women.

•Patients who participated in another clinical study within 4 weeks prior to screening and were administered investigational products or were applied investigational medical devices.

•Patients who were administered the study drug (GV1001) of this clinical study within 12 months prior to screening.

•Patients who participated in a clinical study for progressive supranuclear palsy within 6 months prior to screening.

•Other patients judged by the investigator as ineligible to participate in this clinical study.

Endpoints (44)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Global cognition

40 endpoints

Primary/protocol endpoint

Change From the Baseline in the Total Score of PSP-rating Scale

Time frame:24 weeks(6 months)

ratio, descriptive

Primary/registry result

Change From the Baseline in the Total Score of PSP-rating Scale

Time frame:24 weeks(6 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	4.10	1.69
GV1001 0.56 mgn=20 Participants	2.14	1.78
GV1001 1.12 mgn=25 Participants	6.46	1.64

Secondary/protocol endpoint

Change From the Baseline in the Total Score of PSP-rating Scale

Time frame:12 Weeks(3 months)

ratio, descriptive

Secondary/protocol endpoint

Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)

Time frame:12 weeks (3 Months)

ratio, descriptive

Secondary/protocol endpoint

Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)

Time frame:24 weeks(6 months)

ratio, descriptive

Secondary/protocol endpoint

Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)

Time frame:12 weeks(3 months)

ratio, descriptive

Secondary/protocol endpoint

Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)

Time frame:24 weeks(6 months)

ratio, descriptive

Secondary/protocol endpoint

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)

Time frame:12 weeks(3 months)

ratio, descriptive

Secondary/protocol endpoint

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)

Time frame:24 weeks(6 months)

ratio, descriptive

Secondary/protocol endpoint

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation)

Time frame:12 weeks(3 months)

ratio, descriptive

Secondary/protocol endpoint

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation)

Time frame:24 weeks(6 months)

ratio, descriptive

Secondary/protocol endpoint

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar)

Time frame:12 weeks(3 months)

ratio, descriptive

Secondary/protocol endpoint

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar)

Time frame:24 weeks(6 months)

ratio, descriptive

Secondary/protocol endpoint

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor)

Time frame:12 weeks(3 months)

ratio, descriptive

Secondary/protocol endpoint

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor)

Time frame:24 weeks(6 months)

ratio, descriptive

Secondary/protocol endpoint

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor)

Time frame:12 weeks(3 months)

ratio, descriptive

Secondary/protocol endpoint

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor)

Time frame:24 weeks(6 months)

ratio, descriptive

Secondary/protocol endpoint

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait)

Time frame:12 weeks(3 months)

ratio, descriptive

Secondary/protocol endpoint

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait)

Time frame:24 weeks(6 months)

ratio, descriptive

Secondary/protocol endpoint

Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria)

Time frame:12 weeks(3 months)

ratio, descriptive

Secondary/protocol endpoint

Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria)

Time frame:24 weeks(6 months)

ratio, descriptive

Secondary/registry result

Change From the Baseline in the Total Score of PSP-rating Scale

Time frame:12 Weeks(3 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	1.42	1.60
GV1001 0.56 mgn=22 Participants	-0.47	1.65
GV1001 1.12 mgn=26 Participants	2.75	1.55

Secondary/registry result

Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)

Time frame:12 weeks (3 Months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	0.25	0.61
GV1001 0.56 mgn=22 Participants	0.93	0.64
GV1001 1.12 mgn=26 Participants	0.26	0.60

Secondary/registry result

Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)

Time frame:24 weeks(6 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	0.29	0.73
GV1001 0.56 mgn=20 Participants	0.35	0.78
GV1001 1.12 mgn=25 Participants	-1.46	0.71

Secondary/registry result

Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)

Time frame:12 weeks(3 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	-0.29	0.51
GV1001 0.56 mgn=22 Participants	-1.06	0.53
GV1001 1.12 mgn=26 Participants	-1.42	0.49

Secondary/registry result

Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)

Time frame:24 weeks(6 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	-0.20	0.55
GV1001 0.56 mgn=20 Participants	-0.89	0.59
GV1001 1.12 mgn=25 Participants	-1.42	0.54

Secondary/registry result

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)

Time frame:12 weeks(3 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	-0.26	0.56
GV1001 0.56 mgn=22 Participants	-0.17	0.59
GV1001 1.12 mgn=26 Participants	0.41	0.55

Secondary/registry result

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (History)

Time frame:24 weeks(6 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	0.42	0.66
GV1001 0.56 mgn=20 Participants	0.90	0.70
GV1001 1.12 mgn=25 Participants	1.36	0.64

Secondary/registry result

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation)

Time frame:12 weeks(3 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	0.31	0.41
GV1001 0.56 mgn=22 Participants	-0.01	0.41
GV1001 1.12 mgn=26 Participants	0.23	0.39

Secondary/registry result

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Mentation)

Time frame:24 weeks(6 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	0.26	0.41
GV1001 0.56 mgn=20 Participants	-0.07	0.43
GV1001 1.12 mgn=25 Participants	0.66	0.40

Secondary/registry result

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar)

Time frame:12 weeks(3 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	0.35	0.24
GV1001 0.56 mgn=22 Participants	0.11	0.25
GV1001 1.12 mgn=26 Participants	-0.08	0.24

Secondary/registry result

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Bulbar)

Time frame:24 weeks(6 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	0.49	0.26
GV1001 0.56 mgn=20 Participants	0.04	0.28
GV1001 1.12 mgn=25 Participants	0.68	0.26

Secondary/registry result

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor)

Time frame:12 weeks(3 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	-0.05	0.48
GV1001 0.56 mgn=22 Participants	0.08	0.49
GV1001 1.12 mgn=26 Participants	0.86	0.46

Secondary/registry result

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Ocular Motor)

Time frame:24 weeks(6 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	1.36	0.44
GV1001 0.56 mgn=20 Participants	0.25	0.46
GV1001 1.12 mgn=25 Participants	1.30	0.43

Secondary/registry result

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor)

Time frame:12 weeks(3 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	0.27	0.36
GV1001 0.56 mgn=22 Participants	-0.26	0.38
GV1001 1.12 mgn=26 Participants	0.02	0.36

Secondary/registry result

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Limb Motor)

Time frame:24 weeks(6 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	0.45	0.52
GV1001 0.56 mgn=20 Participants	-0.07	0.55
GV1001 1.12 mgn=25 Participants	0.51	0.50

Secondary/registry result

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait)

Time frame:12 weeks(3 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	0.26	0.47
GV1001 0.56 mgn=22 Participants	-0.08	0.49
GV1001 1.12 mgn=26 Participants	1.19	0.46

Secondary/registry result

Change From the Baseline in the Score of Each Domain of the PSP-rating Scale (Midline/Gait)

Time frame:24 weeks(6 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	0.58	0.56
GV1001 0.56 mgn=20 Participants	1.28	0.59
GV1001 1.12 mgn=25 Participants	1.79	0.54

Secondary/registry result

Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria)

Time frame:12 weeks(3 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	0.21	0.15
GV1001 0.56 mgn=22 Participants	0.13	0.15
GV1001 1.12 mgn=26 Participants	0.06	0.14

Secondary/registry result

Change From the Baseline in the Score of Each Item of the PSP-rating Scale(Item 12_Dysarthria)

Time frame:24 weeks(6 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	0.44	0.14
GV1001 0.56 mgn=20 Participants	0.01	0.15
GV1001 1.12 mgn=25 Participants	0.44	0.14

Function / daily living

4 endpoints

Secondary/protocol endpoint

Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale

Time frame:12 weeks(3 months)

ratio, descriptive

Secondary/protocol endpoint

Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale

Time frame:24 weeks(6 months)

ratio, descriptive

Secondary/registry result

Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale

Time frame:12 weeks(3 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	-2.18	2.92
GV1001 0.56 mgn=22 Participants	-2.70	3.02
GV1001 1.12 mgn=26 Participants	-7.12	2.85

Secondary/registry result

Change From the Baseline in the England & Schwab Activity of Daily Living (ES ADL) Scale

Time frame:24 weeks(6 months)

ratio, descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Placebon=22 Participants	-9.45	3.05
GV1001 0.56 mgn=20 Participants	-8.35	3.23
GV1001 1.12 mgn=25 Participants	-17.12	2.99

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.